Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer (LISA)

The primary objective of this trial is to evaluate the effect of the addition of a 2 year, centrally delivered individualized, telephone-based lifestyle intervention focusing on weight management to a mailed educational intervention on Disease Free Survival in post-menopausal women with early stage breast cancer (hormone receptor positive), BMI ≥24-<40 kg/m2, who are receiving standard letrozole adjuvant therapy.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Mail-based; Behavioral: Lifestyle intervention

Detailed Description

The primary objective of this trial is to evaluate the effect of the addition of a 2 year, centrally delivered individualized, telephone-based lifestyle intervention focusing on weight management to a mailed educational intervention on Disease Free Survival in post-menopausal women with early stage breast cancer (hormone receptor positive), BMI ≥24-<40 kg/m2, who are receiving standard letrozole adjuvant therapy. The telephone intervention will involve 19 phone calls, as well as mailings and a participant manual; women will be asked to lose up to 10% of their weight by reducing their caloric and fat intake (by 500-1000 kcal/day, 20% calories fat) and increasing their moderate physical activity (to 150-200 minutes/week). Secondary outcomes include overall survival, distant disease-free survival, weight change, health-related quality of life (HRQOL), selected non-cancer medical events and biologic factors (notably insulin). Approximately 2,150 women will be enrolled; follow-up will continue until target event rates have been met (anticipated 4-6 years after completion of the intervention). This sample size will provide 80% power (type 1 error 0.05 2-tailed) to detect a hazard ratio (HR) for DFS of 0.74-0.76 in the weight loss intervention arm.

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • Bcca - Csi
  • Ontario
    • Cambridge, Ontario, Canada, N1R 3G2
      • Cambridge Memorial Hospital
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Regional Cancer Centere
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Regional Cancer Centre
    • Sault Ste. Marie, Ontario, Canada, P6A 2C4
      • Algoma District Cancer Program
    • Scarborough, Ontario, Canada, M1P 2V5
      • Scarborough Hospital
    • St. Catharines, Ontario, Canada, L2R 7C6
      • Niagara Health System
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Science Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Odette Cancer Centre
    • Toronto, Ontario, Canada, M9C 1A5
      • Trillium Healthcare Centre
    • Windsor, Ontario, Canada, N8W 2X3
      • Windsor Regional Cancer Centre
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hôpital Charles LeMoyne
    • Montreal, Quebec, Canada, H2W 1T8
      • CHUM - Hotel Dieu de Montreal
• United States
  • California
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical (LABIOMED) Research Institue at Harbor-UCLA Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Centre
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Post-menopausal woman with a diagnosis of invasive breast cancer (T1-3,pN0-2,M0) for which definitive surgery was performed during the previous 36 months.
• On adjuvant hormonal therapy with letrozole at time of randomization (either as initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal therapy).
• BMI ≥ 24 kg/m2.
• Medical, surgical or radiation oncologist agrees to subject participation in a diet and physical activity program.

Exclusion Criteria:

• Life expectancy less than five years.
• Self-reported inability to walk at least 2 blocks (at any pace).
• Insulin requiring diabetes (telephone directed diet and physical activity changes would be difficult in this population without close coordination with the treating physician). Non-insulin requiring diabetics are eligible for the study.
• Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
• Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
• Psychiatric disorders or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
• Patients on aromatase inhibitors other than letrozole at study entry.
• Known recurrence of breast cancer (local, regional or distant) at any time prior to study entry.
• History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Prior in situ cancer of the breast is not a reason for exclusion.
• Patients not fluent in either English or French (spoken and written).
• Patient unwilling or unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mail-based; Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.	Behavioral: Mail-based; Participants will receive a standardized mail-based intervention focussing on healthy living. This will include mailings at study entry as well as a two year subscription to health magazine.
Experimental: Individualized Lifestyle Intervention; Women randomized to the individualized lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.	Behavioral: Lifestyle intervention; Women randomized to the lifestyle intervention arm will receive an intervention program that consists of individual weight loss, diet and physical activity goals, incorporated into a 2 year standardized, structured telephone and mail-based intervention. In addition to diet and physical activity, the intervention will address behavioural and motivational issues relating to weight management including maintaining motivation, overcoming obstacles to success, relapse prevention, emotional distress, stress and time management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	8 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	8 years
Distant disease-free survival	8 years
Weight at 6, 12, 24, 36, 48 and 60 months compared to baseline	5 years
Health-related quality of life at 6, 12, 24, 36, 48 and 60 months compared to baseline	5 years
Other medical endpoints such as diabetes, cardiovascular disease, arthritis, fasting biomarkers at 12 months compared to baseline (for women participating in a biospecimen substudy)	8 years
Compliance with study procedures.	8 years

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Novartis Pharmaceuticals
• Investigators: Principal Investigator: Pamela J Goodwin, MD, MSc, UHN-Mount Sinai Hospital, Toronto, ON

Publications and helpful links

General Publications

• Goodwin PJ, Segal RJ, Vallis M, Ligibel JA, Pond GR, Robidoux A, Blackburn GL, Findlay B, Gralow JR, Mukherjee S, Levine M, Pritchard KI. Randomized trial of a telephone-based weight loss intervention in postmenopausal women with breast cancer receiving letrozole: the LISA trial. J Clin Oncol. 2014 Jul 20;32(21):2231-9. doi: 10.1200/JCO.2013.53.1517. Epub 2014 Jun 16.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 19, 2007
• First Submitted That Met QC Criteria: April 19, 2007
• First Posted (Estimate): April 20, 2007

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: cancer; breast; adjuvant; weight loss; BMI; lifestyle intervention; letrozole; estrogen receptor positive; post-menopausal; progesterone receptor positive
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OCOG-2007-LISA